Comparative Study of the House Advancement Flap, Rhomboid Flap, and Y-V Anoplasty
Primary Purpose
Anal Stenosis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
house advancement flap group
Rhomboid flap GROUP
Y-V anoplasty GROUP
Sponsored by
About this trial
This is an interventional treatment trial for Anal Stenosis focused on measuring anal stenosis, flaps, anoplasty
Eligibility Criteria
Inclusion Criteria:
- ALL PATIENTS with anal stenosis
Exclusion Criteria:
- Pregnant female
- Malignant stenosis
- Associated anal pathology
- Anal stenosis with a anal diameter more than 20 mm
Sites / Locations
- Mansoura University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
house advancement flap
Rhomboid flap
Y-V anoplasty
Arm Description
house advancement flap
rhomboid flapa was incised in the ischiorectal fossa. Without undermining of its fatty base, the flap was then mobilized into the anal canal so that the tip could be sutured to the top of the strictured area using Vicryl 3/0 sutures
Y-V anoplasty
Outcomes
Primary Outcome Measures
postoperative anal caliber
Secondary Outcome Measures
clinical improvement, complications, recurrence, patient satisfaction, postoperative incontinence, and quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00883571
Brief Title
Comparative Study of the House Advancement Flap, Rhomboid Flap, and Y-V Anoplasty
Official Title
Comparative Study of the House Advancement Flap, Rhomboid Flap, and Y-V Anoplasty in Treatment of Anal Stenosis: A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This prospective randomized study included 60 consecutive patients suffering from anal stenosis in the period from April 2002 to December 2008. They admitted to colorectal surgery unit, Mansoura university hospital, Egypt. According to the classification proposed by Milson and Mazier(5), all patients had moderate to severe anal stenosis. There were 43 males and 17 female with a mean age 34 + 5.2 years ranging from 18 up to 63 years.
Detailed Description
Informed consent was obtained from all patients to be included in the study, after explanations the nature of the disease and possible treatment. This study was approved by local ethical committee.
The patients were then randomized into three groups. The randomization was achieved through computer-generated schedule and its results were sealed into 60 envelopes. The responsible surgeon opened randomly an envelop and, accordingly to the protocol.
Group 1: consists of 20 (14 males and 6 females) patients underwent house door flap.
Group II: consists of 20 patients (16 males and 4 females) underwent romboid flap.
Group III: consists of 20 patients underwent V-Y anoplasty (13 males and 7 females).
In group I: a house flap of healthy tissue was incised to the depth of ischiorectal fat. The flap consisted of skin and subcutaneous tissue. The flap was sufficiently mobilized without undermining its fatty base containing perforating blood vessels. The flap should be loose and easily advanced into the anal canal. When the ''base'' of this house-shaped flap was advanced into the anal canal defect, it was fixed to the top of the excised area with 3/0 Vicryl sutures.
In group II: a rhomboid flap was incised in ischiorectal fossa and was mobilized without undermining of its fatty base into the anal canal so that the tip of rhomboid flap is sutured to the top of strictured area using vicryl 3/0.
In group III: V-Y anoplasty is performed by making a v shaped incision in the perianal skin posteriorly starting from the lower end of the wound resultant from excision of scared area. A V-shaped flap is then dissected with preservation fatty base .The V flap is then advanced into the anal canal so that its tip is sutured to the top of structured area using vicryel 3/0.
Patients were discharged 48 hours after the procedure. A high-fiber diet combined with bulk laxatives with oral antibiotic coverage was recommended after discharge. After each bowel movement, cleansing of the operative site with a sitz bath or shower was prescribed.
Patients were discharged 48 hours after the procedure. A high-fiber diet combined with bulk laxatives with oral antibiotic coverage was recommended after discharge. After each bowel movement, cleansing of the operative site with a sitz bath or shower was prescribed.
The parameters investigated were time of relief of painful defecation, the straining severity, sensation of incomplete evacuation and need for laxative or enema. postoperative anal caliber, healing rate, recurrence, quality of life (QOL) was assessed with Gastrointestinal quality of life index (GIQLI) which is a relatively new and validated tool for measuring the QOL in patients with gastrointestinal diseases. The GIQLI developed by Eypasch and coworkers (6). The questionnaire comprises 36 multidimensional items covering symptoms and physical, emotional, and social dysfunction related to gastrointestinal diseases or their treatments. Each item is scored from 0 to 4 points. The GIQLI score is calculated by simple addition of all item scores so that an overall score of 0 would constitute the worst, while a score of 144 (36 X 4) represents the best possible result. It is also possible to evaluate the disease-specific, social, psychologic, and physical items as separate subgroups. The patients were asked to complete the GIQLI questionnaire at admission to the hospital and one year after surgery under the supervision of the same independent authors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Stenosis
Keywords
anal stenosis, flaps, anoplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
house advancement flap
Arm Type
Active Comparator
Arm Description
house advancement flap
Arm Title
Rhomboid flap
Arm Type
Active Comparator
Arm Description
rhomboid flapa was incised in the ischiorectal fossa. Without undermining of its fatty base, the flap was then mobilized into the anal canal so that the tip could be sutured to the top of the strictured area using Vicryl 3/0 sutures
Arm Title
Y-V anoplasty
Arm Type
Active Comparator
Arm Description
Y-V anoplasty
Intervention Type
Procedure
Intervention Name(s)
house advancement flap group
Other Intervention Name(s)
group 1
Intervention Description
A house flap of healthy tissue was incised to the depth of ischiorectal fat. The flap consisted of skin and subcutaneous tissue. The flap was sufficiently mobilized without undermining its fatty base containing perforating blood vessels. The flap should be loose and easily advanced into the anal canal. When the ''base'' of this house-shaped flap was advanced into the anal canal defect, it was fixed to the top of the excised area with 3/0 Vicryl sutures.
Intervention Type
Procedure
Intervention Name(s)
Rhomboid flap GROUP
Other Intervention Name(s)
Group 11
Intervention Description
A rhomboid flap was incised in ischeorectal fossa and was mobilized without undermining of its fatty base into the anal canal so that the tip of rhomboid flap is sutured to the top of stricured area using vicryl 3/0.
Intervention Type
Procedure
Intervention Name(s)
Y-V anoplasty GROUP
Other Intervention Name(s)
group 111
Intervention Description
Y-V anoplastyis performed by making a v shaped incision in the perianal skin posteriorly starting from the lower end of the wound resultant from excision of scared area. A V-shaped flap is then dissected with preservation fatty base .The V flap is then advanced into the anal canal so that its tip is sutured to the top of structured area using vicryel 3/0.
Primary Outcome Measure Information:
Title
postoperative anal caliber
Time Frame
1 year
Secondary Outcome Measure Information:
Title
clinical improvement, complications, recurrence, patient satisfaction, postoperative incontinence, and quality of life
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ALL PATIENTS with anal stenosis
Exclusion Criteria:
Pregnant female
Malignant stenosis
Associated anal pathology
Anal stenosis with a anal diameter more than 20 mm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamed yousef
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University
City
Mansoura
ZIP/Postal Code
35111
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
15838576
Citation
Habr-Gama A, Sobrado CW, de Araujo SE, Nahas SC, Birbojm I, Nahas CS, Kiss DR. Surgical treatment of anal stenosis: assessment of 77 anoplasties. Clinics (Sao Paulo). 2005 Feb;60(1):17-20. doi: 10.1590/s1807-59322005000100005. Epub 2005 Mar 1.
Results Reference
result
PubMed Identifier
18679744
Citation
Alver O, Ersoy YE, Aydemir I, Erguney S, Teksoz S, Apaydin B, Ertem M. Use of "house" advancement flap in anorectal diseases. World J Surg. 2008 Oct;32(10):2281-6. doi: 10.1007/s00268-008-9699-1.
Results Reference
result
PubMed Identifier
7749697
Citation
Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmulling C, Neugebauer E, Troidl H. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg. 1995 Feb;82(2):216-22. doi: 10.1002/bjs.1800820229.
Results Reference
result
Links:
URL
http://www.mans.edu.eg/
Description
mansoura university hospital
Learn more about this trial
Comparative Study of the House Advancement Flap, Rhomboid Flap, and Y-V Anoplasty
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